Building on the success of previous events, SMi proudly announces the return of its 5th Annual Biosimilars USA Conference, taking place in New Jersey on the 14th and 15th November 2018.

This fifth event in the series will gather a global audience of biosimilar experts and industry-thought leaders to discuss biosimilar manufacturing and commercialization considerations specific to the U.S..

On March 7th, 2018, the U.S.-FDA’s Commissioner, Scott Gottlieb, MD, announced that Biosimilar medicines are now atop priority for the FDA. Join us this November to learn how to take advantage of the FDA’s focus on biosimilars, accelerate your biosimilar pipeline and achieve FDA approval.

This year's conference will home-in on how to circumvent regulatory hindrances and expediting the approvals process for your biosimilars pipeline. Experience will be drawn from a range of expert perspectives, to allow you to benchmark your business practices and learn how to streamline your processes.

Hear from a selection of carefully handpicked keynote addresses and case studies presented to you by top manufacturing and leading distributors of market approved biosimilars, as they offer a unique insight into the areas of manufacturing, commercialization, device design, uptake, switching, interchangeability, and regulations.

“If we’re serious about seeing the market for biosimilars take shape, it’s going to require a payment system that gives products that are currently in the pipeline a chance to enter the market once they’re approved…. The FDA will do its part by laying out an efficient path for showing how biosimilar products can demonstrate interchangeability with their branded counterparts. But we can solve only one part of this equation.”

- Quote from Scott Gottlieb, MD, Commissioner of Food and Drugs Speech titled “Capturing the Benefits of Competition for Patients” Full transcript can be found here.

Biosimilars is a very dynamic market and not only from a competitive environment perspective, but the Intellectual Property (IP), Policy and Regulatory Environment will continue to evolve.

There are 5 main ingredients to achieving a vibrant, sustainable environment for biosimilars that benefits patients, healthcare systems and industry:
o Fair and early access to market,
o appropriate pricing,
o biosimilars from several competitors on the market,
o broad insurance coverage, and
o educated and supportive physicians and patients.

As an industry, we must unite to ensure health systems are ready to realise the potential of biosimilars in the US, and around the world

9:50 New Dance Moves: How recent caselaw has reshaped the BPCIA patent dance

A discussion looking at several of the recent US case law rulings that have significantly altered the canonical timeline for BPCIA litigation, and how biosimilars makers can potentially navigate those changes
A discussion on how the Amgen v. Sandoz Supreme Court case has opened the door to bypassing the patent dance and accelerating the time period for pre-launch declaratory judgment litigation
A discussion on the potential for pre-launch damages litigation, as were awarded in the Amgen v. Hospira district court decision
A discussion on how, whether and when to disclose biosimilar manufacturing info, as was the subject of the Amgen v. Hospira Fed Cir decision
A discussion on the recent skirmishes in California over choice of venue, as in the pending Amgen v. Genentech and Celltrion v. Genentech matters
A discussion of the FDA’s process for approving biosimilar applications, and how the FDA’s approval timeline syncs up (or does not) with the BPCIA’s “expected” litigation timeline

Christopher Loh, Partner, FITZPATRICK, CELLA, HARPER & SCINTO

Peter Waibel, Head of US Patent Litigation, Novartis

10:30 Morning Coffee

- IPR and PGR process, strategic differences between those and district court litigation
- Statistics demonstrating the particular impact of these venues on biologic products
- General strategy as to how to prepare for them from both the BLA holder and aBLA filer perspective.

Prof. Sarfaraz K. Niazi, Founding Chairman of Karyo Biologics, Founder and Ex-Executive Chairman of Adello Biologics, and Adj. Professor of Biopharmaceutical Sciences, University of Illinois, has developed several biosimilar products, written 50+ major textbooks and handbooks, authored 100+ research papers, and owns the largest number of bioprocessing patents. He is a major contributor to the the BPCIA and the FDA guidance that followed. Dr. Niazi’s Citizen Petitions on bioequivalence testing and biosimilar development have been accepted by the FDA. www.niazi.com; www.karyobio.com; niazi@niazi.com

FDA to eliminate bridging test, make statistical equivalence criteria clinically relevant and allow in vitro immunogenicity where available

The FDA, the prescribers and the payers jointly promote the use of biosimilars as first choice for new patients, given that there is no clinically meaningful difference

The developers to concentrate on fingerprint like similarity rather than offering to do studies in patients

12:20 Networking Lunch

13:20 Risk evaluation of Biosimilars and downstream implications for operations and commercialization

Edric Engert is Managing Director of Abraxeolus Consulting and has over 20 years of experience in the healthcare industry. He offers problem solving leadership and expertise in such areas as strategy, its operationalization, business development/in-licensing, portfolio strategy, selection, and management, operational improvement programs and turnarounds, and M&A. He has advised a broad range of clients in such industries as Biosimilars, Generics, Branded Pharmaceuticals, API, Healthcare Information Exchanges, distributors, trade associations, and not-for-profit agencies.

Prior roles included Head of the Biosimilars Business at Teva, leading Generics portfolio, BD, strategy, and API sourcing at companies like Sandoz and Teva, and consultant at McKinsey & Company’s health care practice. Edric holds an MBA from Wharton and a BS in Mathematics from MIT.

• External risks that are systemic to Biosimilars and internal risks that each Biosimilar firm likely faces
• Understanding the approaches needed for operations and commercialization in both planning and execution
• Examples of key drivers, incentives, and what components must be known and considered with example quantification of resulting market dynamics
• An outline of resulting to-do's that any Biosimilar firm engaged in commercialization needs to cover to be successful in their launch and beyond

14:00 Switching form Reference Biologics to Biosimilars

Dr. Hillel Cohen leads Scientific Affairs efforts for Sandoz in the Americas where he helps explain the science-based Sandoz and Novartis biosimilar policy positions to the healthcare community, the public, and health authorities. He has been active in field of biosimilars since 2002, when discussions about them were initiated in the US.

Dr. Cohen has been active in biosimilar trade associations in a variety of roles, including leadership roles at the Biosimilars Forum and at the Biosimilars Council (a division of the Association for Affordable Medicines).

Dr. Cohen has over 25 years of industry experience. He is an expert in regulatory science policy and biologic product development. Before joining Scientific Affairs at Sandoz, he was the Head of Global Strategic Labeling as well as the Head of Regulatory Affairs for the Americas at Novartis Vaccines. Hillel has held leadership positions in biotechnology QC, bioanalytical chemistry, and regulatory affairs at other firms.

Dr. Cohen received a BA from NYU and a PhD in Biology from Dartmouth.

Scientific literature was reviewed from 1993 to June 30, 2017 to identify publications that described switching from reference biologic to a biosimilar

Ninety studies were identified, involving 7 molecules used to treat 14 disease indications, enrolling a total of 14,225 individuals

The great majority of studies did not report differences in safety, efficacy or immunogenicity

The results suggest a low risk of either a safety concern or loss of efficacy after switching to a biosimilar

14:40 Afternoon Tea

15:20 Biosimilars Interchangeability: The Draft Regulatory Guidance in the USA

Michel Mikhail, International Expert in Regulatory Affairs, International Expert in Biosimilars, Independant Consultant

16:00 PANEL: How sustainable is the biosimilars market?

Christina Yunis, Global Biosimilars Market Development Lead, Pfizer

Where is the market heading?

Who will be the relevant players and where will they be based globally?

Will we see a migration of manufactures to low cost countries as we did with generics?

What are the short and long-term gains?

In 10 years’ time, will there still be a market that can make profit?

17:00 Chairman’s Closing Remarks and Close of Day One

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Michel Mikhail, International Expert in Regulatory Affairs, International Expert in Biosimilars, Independant Consultant

9:10 Recent Expected and Unexpected Developments in Biosimilar Drug Development

Dr Nigel Rulewski MD, DCH, DRCOG is Vice President and Head of the Biosimilar Center of Excellence at IQVIA. Dr Rulewski has over 25 years of experience in the pharmaceutical industry.
He has been involved in all stages of development of biosimilar products for approval in the US, EU and major global markets. Prior to joining IQVIA, Dr. Rulewski served as Chief Medical Officer at Astra USA, Fisons, Serono, Procept and ArQule. He has managed FDA Advisory Committee meetings, and interacted with the FDA on numerous drug development projects in diverse therapeutic areas resulting in seven successful US approvals. He also served as a consultant working in venture capital in the US funding biotech startup companies. During the development of the AIDS crisis, Dr. Rulewski was media trained and acted as a company spokesperson on sensitive drug development issues handling both press and TV interviews. He received his medical training at St Bartholomew’s Medical School, University of London and completed post graduate training in Obstetrics and Gynecology, (Diploma in Child Health, Royal College of Physicians) and Pediatrics

US interchangeability requirements in the US

Use of Next Generational Tools and novel paradigms to accelerate the clinical development cycle

Steps that innovator companies have taken to block biosimilar development

Steps being taken to erode the “patent dance” in the US

The potential for using a global reference comparator

The possibility of abbreviating the biosimilar development pathway

The emergence and ramifications of the ‘Nocebo Effect”

9:50 Developing biosimilars with a tobacco plant expression system

Dr. Stewart, an entrepreneur and scientist bringing 30 years’ experience in the biotechnology industry to this role. Dr. Stewart has founded a biotechnology company, PlantForm Corporation. At PlantForm Dr. Stewart has developed the company from a start-up, directing fundraising, the development of a strong intellectual property portfolio and implementation of partnerships with Pharmaceutical Companies, Government Organizations and Foundations.

Previously, as the Director Research and Development for Cangene Corporation, Dr. Stewart was responsible for the company’s research and development group. Dr. Stewart led collaborative programs developing innovative and biosimilar drugs as medical countermeasures and as traditional therapeutics.

Dr. Stewart graduated with a PhD from the University of London, UK and gained academic experience at the University of Alberta in Edmonton, Canada.

Drug production using plant based and other expression systems

Regulatory environment for non-traditional expression systems

Partnerships using alternative expression systems to develop biosimilars and biobetters

10:30 Morning Coffee

11:00 In-licensing biosimilars: Best practices for completing diligence and executing the contract successfully

Arun Nataraj has over 17 years of Business Development & Licensing experience in the Pharma Industry. After spending a decade in pharma manufacturing organizations, most recently at Lonza, where his roles included leading licensing for Lonza’s leading mammalian expression system, Arun then switched over to the “buy side” by joining Amneal Pharma, where he worked until recently, and led BD&L activities for the US market. During his career, Arun has completed over a hundred transactions, from In/Out Licensing of Products & Technology Platforms; Technology Transfers; Manufacturing agreements for Products & Devices; and Commercial Distribution Arrangements. Arun has a PhD in Molecular Biology from the MD Anderson Cancer Center and an MBA from Cornell University.

• Gap analysis in the data during due diligence and Partners plans to address them. FDA correspondence following Pre-IND and pre-BLA meetings
• The importance of outside consultants and their role in due diligence
• Structuring a deal to de-risk your investment until there is confidence in the program
• Critical contractual issues that need to be negotiated in a favourable manner (to you)

11:40 Canadian Regulatory Perspective on Biosimilars

Catherine Soo holds a PhD in Pharmacology and joined Health Canada in 2011 as a Regulatory Project Manager in the Therapeutic Products Directorate (TPD), Health Products and Food Branch. Shortly after joining, she moved into a review position within the Bureau of Pharmaceutical Sciences, TPD, where she focused on the review of generic pharmaceuticals. Since 2015, Catherine has been working in the Biologics and Genetic Therapies Directorate as a Senior Clinical Evaluator on the review of biologics products, including biosimilars. Catherine therefore has extensive experience in the review of bioequivalence and comparative bioavailability studies in both the pharmaceutical and biologics areas, as well as knowledge of the regulatory requirements for filing.

Regulatory Framework – the Canadian Food and Drugs Act and Regulations and Health Canada’s Guidance Documents on the Information and Submission Requirements for Biosimilars

Clinical requirements for biosimilar drug submissions

Intersect of Patented Medicines and the approval process for Biosimilars

Roles of the Federal versus Provincial Jurisdictions

Authorised/marketed Biosimilars in Canada

12:20 Networking Lunch

13:20 Biosimilars – can they all survive?

13:20 Do biosimilars really need Real World Evidence?

Anita Burrell is a dynamic, passionate and infectiously enthusiastic consultant focused on improving patient outcomes through pharmaceutical innovation. She is also an adjunct assistant professor at Rutgers University and a regular speaker in the industry on health economics, market access and mHealth.

Anita has 23 years of leadership experience in the pharmaceutical industry in a wide variety of roles and geographies. As the Global Project Lead for Aubagio, the oral MS therapy from Genzyme, she was able to bring Aubagio to market over eight months ahead of schedule becoming the second oral therapy to market in the USA and EU. Aubagio is the fastest growing MS product in the US and the #1 product in the Genzyme/Sanofi portfolio with revenue of €1.6B in 2017.

As a consultant Anita has helped companies to:
Understand market dynamics and payer behavior in diabetes and MS
Design big data platforms to deliver value in terms of regional sales variations
Develop predictive models to inform HTA submissions
Understand the implications of digital health and possibilities to use behavioural economics

Anita holds a BA (Hons) in Economics from the University of Stirling, an M.A. in Economics from Dalhousie University, Nova Scotia, Canada, and a Masters in Business Administration from Kingston University, Surrey UK. She speaks French at an advanced level.

Dr Nigel Rulewski MD, DCH, DRCOG is Vice President and Head of the Biosimilar Center of Excellence at IQVIA. Dr Rulewski has over 25 years of experience in the pharmaceutical industry.
He has been involved in all stages of development of biosimilar products for approval in the US, EU and major global markets. Prior to joining IQVIA, Dr. Rulewski served as Chief Medical Officer at Astra USA, Fisons, Serono, Procept and ArQule. He has managed FDA Advisory Committee meetings, and interacted with the FDA on numerous drug development projects in diverse therapeutic areas resulting in seven successful US approvals. He also served as a consultant working in venture capital in the US funding biotech startup companies. During the development of the AIDS crisis, Dr. Rulewski was media trained and acted as a company spokesperson on sensitive drug development issues handling both press and TV interviews. He received his medical training at St Bartholomew’s Medical School, University of London and completed post graduate training in Obstetrics and Gynecology, (Diploma in Child Health, Royal College of Physicians) and Pediatrics

Edric Engert is Managing Director of Abraxeolus Consulting and has over 20 years of experience in the healthcare industry. He offers problem solving leadership and expertise in such areas as strategy, its operationalization, business development/in-licensing, portfolio strategy, selection, and management, operational improvement programs and turnarounds, and M&A. He has advised a broad range of clients in such industries as Biosimilars, Generics, Branded Pharmaceuticals, API, Healthcare Information Exchanges, distributors, trade associations, and not-for-profit agencies.

Prior roles included Head of the Biosimilars Business at Teva, leading Generics portfolio, BD, strategy, and API sourcing at companies like Sandoz and Teva, and consultant at McKinsey & Company’s health care practice. Edric holds an MBA from Wharton and a BS in Mathematics from MIT.

Michel Mikhail, International Expert in Regulatory Affairs, International Expert in Biosimilars, Independant Consultant

15:40 Chairman’s Closing Remarks and Close of Day Two

FEATURED SPEAKERS

Dr. Stewart, an entrepreneur and scientist bringing 30 years’ experience in the biotechnology industry to this role. Dr. Stewart has founded a biotechnology company, PlantForm Corporation. At PlantForm Dr. Stewart has developed the company from a start-up, directing fundraising, the development of a strong intellectual property portfolio and implementation of partnerships with Pharmaceutical Companies, Government Organizations and Foundations.

Previously, as the Director Research and Development for Cangene Corporation, Dr. Stewart was responsible for the company’s research and development group. Dr. Stewart led collaborative programs developing innovative and biosimilar drugs as medical countermeasures and as traditional therapeutics.

Dr. Stewart graduated with a PhD from the University of London, UK and gained academic experience at the University of Alberta in Edmonton, Canada.

Dr. Hillel Cohen leads Scientific Affairs efforts for Sandoz in the Americas where he helps explain the science-based Sandoz and Novartis biosimilar policy positions to the healthcare community, the public, and health authorities. He has been active in field of biosimilars since 2002, when discussions about them were initiated in the US.

Dr. Cohen has been active in biosimilar trade associations in a variety of roles, including leadership roles at the Biosimilars Forum and at the Biosimilars Council (a division of the Association for Affordable Medicines).

Dr. Cohen has over 25 years of industry experience. He is an expert in regulatory science policy and biologic product development. Before joining Scientific Affairs at Sandoz, he was the Head of Global Strategic Labeling as well as the Head of Regulatory Affairs for the Americas at Novartis Vaccines. Hillel has held leadership positions in biotechnology QC, bioanalytical chemistry, and regulatory affairs at other firms.

Anita Burrell

VP, Global Market Access, Eversana

Anita Burrell is a dynamic, passionate and infectiously enthusiastic consultant focused on improving patient outcomes through pharmaceutical innovation. She is also an adjunct assistant professor at Rutgers University and a regular speaker in the industry on health economics, market access and mHealth.

Anita has 23 years of leadership experience in the pharmaceutical industry in a wide variety of roles and geographies. As the Global Project Lead for Aubagio, the oral MS therapy from Genzyme, she was able to bring Aubagio to market over eight months ahead of schedule becoming the second oral therapy to market in the USA and EU. Aubagio is the fastest growing MS product in the US and the #1 product in the Genzyme/Sanofi portfolio with revenue of €1.6B in 2017.

As a consultant Anita has helped companies to:
Understand market dynamics and payer behavior in diabetes and MS
Design big data platforms to deliver value in terms of regional sales variations
Develop predictive models to inform HTA submissions
Understand the implications of digital health and possibilities to use behavioural economics

Anita holds a BA (Hons) in Economics from the University of Stirling, an M.A. in Economics from Dalhousie University, Nova Scotia, Canada, and a Masters in Business Administration from Kingston University, Surrey UK. She speaks French at an advanced level.

For more insight visit https://www.linkedin.com/in/anitaburrell

Arun Nataraj

Business Development and Licensing Executive , Vermont Biosynthetics LLC

Arun Nataraj has over 17 years of Business Development & Licensing experience in the Pharma Industry. After spending a decade in pharma manufacturing organizations, most recently at Lonza, where his roles included leading licensing for Lonza’s leading mammalian expression system, Arun then switched over to the “buy side” by joining Amneal Pharma, where he worked until recently, and led BD&L activities for the US market. During his career, Arun has completed over a hundred transactions, from In/Out Licensing of Products & Technology Platforms; Technology Transfers; Manufacturing agreements for Products & Devices; and Commercial Distribution Arrangements. Arun has a PhD in Molecular Biology from the MD Anderson Cancer Center and an MBA from Cornell University.

Catherine Soo

Senior Clinical Evaluator, Health Canada

Catherine Soo holds a PhD in Pharmacology and joined Health Canada in 2011 as a Regulatory Project Manager in the Therapeutic Products Directorate (TPD), Health Products and Food Branch. Shortly after joining, she moved into a review position within the Bureau of Pharmaceutical Sciences, TPD, where she focused on the review of generic pharmaceuticals. Since 2015, Catherine has been working in the Biologics and Genetic Therapies Directorate as a Senior Clinical Evaluator on the review of biologics products, including biosimilars. Catherine therefore has extensive experience in the review of bioequivalence and comparative bioavailability studies in both the pharmaceutical and biologics areas, as well as knowledge of the regulatory requirements for filing.

Christina Yunis

Global Biosimilars Market Development Lead, Pfizer

Christopher Loh

Partner, FITZPATRICK, CELLA, HARPER & SCINTO

Don Stewart

CEO, PlantForm Corp

Don Stewart, PhD

Dr. Stewart, an entrepreneur and scientist bringing 30 years’ experience in the biotechnology industry to this role. Dr. Stewart has founded a biotechnology company, PlantForm Corporation. At PlantForm Dr. Stewart has developed the company from a start-up, directing fundraising, the development of a strong intellectual property portfolio and implementation of partnerships with Pharmaceutical Companies, Government Organizations and Foundations.

Previously, as the Director Research and Development for Cangene Corporation, Dr. Stewart was responsible for the company’s research and development group. Dr. Stewart led collaborative programs developing innovative and biosimilar drugs as medical countermeasures and as traditional therapeutics.

Dr. Stewart graduated with a PhD from the University of London, UK and gained academic experience at the University of Alberta in Edmonton, Canada.

Edric Engert

Managing Director , Abraxeolus Consulting

Edric Engert is Managing Director of Abraxeolus Consulting and has over 20 years of experience in the healthcare industry. He offers problem solving leadership and expertise in such areas as strategy, its operationalization, business development/in-licensing, portfolio strategy, selection, and management, operational improvement programs and turnarounds, and M&A. He has advised a broad range of clients in such industries as Biosimilars, Generics, Branded Pharmaceuticals, API, Healthcare Information Exchanges, distributors, trade associations, and not-for-profit agencies.

Prior roles included Head of the Biosimilars Business at Teva, leading Generics portfolio, BD, strategy, and API sourcing at companies like Sandoz and Teva, and consultant at McKinsey & Company’s health care practice. Edric holds an MBA from Wharton and a BS in Mathematics from MIT.

Ha Kung Wong

Partner, New York, FITZPATRICK, CELLA, HARPER & SCINTO

Hillel Cohen

Executive Director, Scientific Affairs, Sandoz Inc

Dr. Hillel Cohen leads Scientific Affairs efforts for Sandoz in the Americas where he helps explain the science-based Sandoz and Novartis biosimilar policy positions to the healthcare community, the public, and health authorities. He has been active in field of biosimilars since 2002, when discussions about them were initiated in the US.

Dr. Cohen has been active in biosimilar trade associations in a variety of roles, including leadership roles at the Biosimilars Forum and at the Biosimilars Council (a division of the Association for Affordable Medicines).

Dr. Cohen has over 25 years of industry experience. He is an expert in regulatory science policy and biologic product development. Before joining Scientific Affairs at Sandoz, he was the Head of Global Strategic Labeling as well as the Head of Regulatory Affairs for the Americas at Novartis Vaccines. Hillel has held leadership positions in biotechnology QC, bioanalytical chemistry, and regulatory affairs at other firms.

HoUng Kim

John Kirkland

Michel Mikhail

International Expert in Regulatory Affairs, International Expert in Biosimilars, Independant Consultant

Nigel Rulewski

Vice President, Head Biosimilar Center of Excellence, IQVIA

Dr Nigel Rulewski MD, DCH, DRCOG is Vice President and Head of the Biosimilar Center of Excellence at IQVIA. Dr Rulewski has over 25 years of experience in the pharmaceutical industry.
He has been involved in all stages of development of biosimilar products for approval in the US, EU and major global markets. Prior to joining IQVIA, Dr. Rulewski served as Chief Medical Officer at Astra USA, Fisons, Serono, Procept and ArQule. He has managed FDA Advisory Committee meetings, and interacted with the FDA on numerous drug development projects in diverse therapeutic areas resulting in seven successful US approvals. He also served as a consultant working in venture capital in the US funding biotech startup companies. During the development of the AIDS crisis, Dr. Rulewski was media trained and acted as a company spokesperson on sensitive drug development issues handling both press and TV interviews. He received his medical training at St Bartholomew’s Medical School, University of London and completed post graduate training in Obstetrics and Gynecology, (Diploma in Child Health, Royal College of Physicians) and Pediatrics

Peter Waibel

Head of US Patent Litigation, Novartis

Sarfaraz Niazi

Founder, Karyo Biologics, LLC

Prof. Sarfaraz K. Niazi, Founding Chairman of Karyo Biologics, Founder and Ex-Executive Chairman of Adello Biologics, and Adj. Professor of Biopharmaceutical Sciences, University of Illinois, has developed several biosimilar products, written 50+ major textbooks and handbooks, authored 100+ research papers, and owns the largest number of bioprocessing patents. He is a major contributor to the the BPCIA and the FDA guidance that followed. Dr. Niazi’s Citizen Petitions on bioequivalence testing and biosimilar development have been accepted by the FDA. www.niazi.com; www.karyobio.com; niazi@niazi.com

Steinar Madsen

Medical Director, Norwegian Medicines Agency

Official Media Partner

View detailsBiosimilar DevelopmentOfficial Media Partnerhttp://www.biosimilardevelopment.com/Biosimilar Development is dedicated to presenting technical information, thought leadership, and commentary for the biosimilar development and manufacturing community. On this site, users will find exclusive and actionable content on the industry trends and challenges affecting the emerging biosimilars market. Browse our articles, case studies, and white papers on topics related to biosimilar development, manufacturing, quality, distribution, FDA guidance, BPCIA, global markets, government regulations, and intellectual property.
Biosimilar Development is part of the Life Science Connect media group, which strives to facilitate connections and foster collaborations in pharmaceutical development to find ways to get more life-saving and life-improving therapies to market. Connect, Collaborate, Contribute.

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Generics and Biosimilars Initiative (GaBI) was founded in 2008. GaBI aims to foster the worldwide efficient use of high quality and safe medicines at an affordable price, thus advancing and supporting the idea of accessible, affordable and sustainable health care.
The objective of GaBI is to raise the scientific status of generic and biosimilar medicines, via well-documented and up-to-date information about generic and biosimilar medicines both in print (www.gabi-journal.net) and electronically (www.gabionline.net) in an open access format, providing high quality, scientifically sound and reliable information to healthcare professionals including physicians, pharmacists and nurses, consumers, drug developers, third-party payers, legislators and assessors; who are in need of a reliable, critical and independent source of information on all aspects of generic and biosimilar medicines.
Subscribe to gain easy access of information on the latest scientific research and developments in generic and biosimilar medicines via GaBI Online to editorial@gabionline.net; or submit a manuscript to GaBI Journal to editorial@gabi-journal.net.
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Articles like latest news, trends, analysis, market report, press releases, whitepapers, case studies, etc. published on pharmajournalist.com helps Industry professionals and decision makers to stay on the top of this fast-paced industry.
Pharma Journalist aims of providing fast and informative articles to its readers and subscribers.

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Health economics experts. Managed care professionals. Key clinical specialists.
This is where the worlds of clinical, regulatory, and economical outcomes for specialized pharmaceutical biotechnology meet: The Center for Biosimilars is your online resource for emerging technologies, with a focus on improving critical thinking in the field to impact patient outcomes.
We’ll discuss the current landscape for advanced health care management—reviewing emerging treatment paradigms, approaches, and considerations—all by authoritative industry voices.

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View detailsAmerican LaboratorySupportershttp://www.americanlaboratory.comFor laboratory managers and researchers utilizing analytical chemistry and its applications, seeking knowledge on new technologies, methods, applications, and products, the American Laboratory® publication platform provides comprehensive technology coverage for laboratory professionals at all stages of their careers. Unlike single-channel publications, American Laboratory® is a multidisciplinary resource that engages scientists through print, digital, mobile, multimedia, and social channels to provide practical information and solutions for cutting-edge results. American Laboratory® serves the need of global community of laboratory professionals for communicating relevant technical advances and insights. Globally, American Laboratory® reaches out to subscribers by offering digital distribution plus premium print in North America. Digital communications utilize internet, mobile and social channels.

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The ASD Media platforms are well known and used intensively, your company is able to benefit from these large numbers of users. Be informed with ASD-Network; Create exposure for your company with ASDSource, distribute your news with ASDWire or advertise with us, build your brand and increase traffic to your company’s website.

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Bentham is offering attendees of this conference discounts on its publication. For more information click here

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View detailsGate2BiotechSupportershttp://www.gate2biotech.comGate2Biotech is a portal that unites biotechnological community in Central Europe. It covers all the news in the field of biotechnology. Thanks to the the portal the companies engaged in the field can easily search for research institutions and other partners to solve technical problems they are facing and here they can also present their services offer to potential partners from the Czech Republic and abroad. Gate2Biotech portal serves as a bridge connecting scientific and commercial sector. It incorporates offices and support organizations dedicated to promoting transfer of innovative technologies into a unified communication platform of Czech and international biotechnologies. As a mediator of information it draws attention to biotechnologies and support of their application and transfer into practice. It also functions as a tool for encouraging non-professionals (especially scientists and students) towards innovative business or applied research.

View detailsLabcompareSupportershttp://www.labcompare.comLabcompare is a product of American Laboratory, and is already included in the AL logo on your website. I have attached the standalone Labcompare logo and info is below, but if you do add this one separately, could you exchange the American Lab logo with the one attached?
For laboratory managers and researcher scientists across analytical chemistry and applied sciences who need to find product solutions, advice, and access scientific tools. Labcompare provides an industry-leading, comprehensive, online resource of product information to support the laboratory’s needs. Labcompare supports every step of the buying journey by focusing on core and new product technology, supplies, tips, and buyer’s guides.

View detailsMednousSupportershttp://www.MedNous.comMedNous is a print publication and website about medical innovation in Europe. It carries exclusive interviews with companies that are at the forefront of medical technology, as well as contributor articles from prominent practitioners. Our mission is to identify significant advances in medicine and to explain how this innovation is being commercialised. In doing so, we talk to venture capitalists about what products and platforms they are supporting. We report on how regulators cope with the accelerating pace of innovation. And we regularly cover the latest developments in the discovery and development of new medical concepts in the area of antibodies, vaccines, small molecules, regenerative medicine and nanomedicines. MedNous combines the English word for medicine with the Greek word for intellect. And those with nous are readers of our publication. Visit our website: www.mednous.com

View detailsOpen Chemistry Supportershttp://www.openchemistry.comOpen Chemistry (IF - 1.425) is a peer-reviewed, open access journal that publishes original research, reviews and short communications in the fields of chemistry in an ongoing way. Our central goal is to provide a hub for researchers working across all subjects to present their discoveries, and to be a forum for the discussion of the important issues in the field.

View detailsPharmaceutical OutsourcingSupportershttp://www.pharmoutsourcing.comPharmaceutical Outsourcing, the journal dedicated to pharmaceutical and biopharmaceutical contract services. With regular sections on contract manufacturing, contract research, contract packaging, formulation/development services, contract analytical testing, APIs, stability testing, clinical research and other areas, we bring the most complete coverage of trends and issues in the industry to our 15,000 readers in North America.

View detailsPharmalicensingSupportershttp://www.pharmalicensing.comPharmalicensing (www.pharmalicensing.com) is the premier biopharmaceutical Open Innovation resource designed for professionals involved with partnering, licensing and business development worldwide.
Actively supporting all forms of partnering and in- and out-licensing activities, Pharmalicensing utilizes the unique online Showcase Profiling & Discover services, as well as its renowned Partnering Search service leveraging its global network of industry experts, to enable companies to identify and engage with appropriate partners around the world.
Pharmalicensing is actively utilized by many tens of thousands of industry professionals each month. Pharmalicensing is a division of Cognis Group, Inc.

View detailspharmaphorumSupportershttp://www.pharmaphorum.compharmaphorum drives innovation within the pharmaceutical industry, by bringing healthcare together through a suite of media services that help produce and disseminate thought leadership, combined with an online platform for communicating messages to a global audience.Visit www.pharmaphorum.com

View detailsSciDoc PublishersSupportershttp://www.scidoc.orgSciDoc Publishers is a major source provider of e-journals in the field of Science, Technology and Medicine (STM). The nature of journals - Open Access and Peer-reviewed. We are aimed with a sole motive in making a mark in the field of Open Access, by propagating the knowledge to the scientific community. Our prime concern involves, the knowledge to reach millions of readers and give them access to scientific publications - online.

View detailsTechnology NetworksSupportershttp://go.technologynetworks.com/subscribe-to-newslettersFounded in 2000, Technology Networks is established as the leading news provider for life science and drug discovery professionals. In addition, we provide unique content including webcasts, videos, application notes and posters from recent conferences. Our portfolio now includes around 30 focussed scientific communities, all of which are accessible free of charge within TechnologyNetworks.com

Workshops

Workshop

VENUE

Renaissance Woodbridge Hotel

515 US Highway 1 South, Iselin, New Jersey, USA

Your simple delights will become memorable moments at Renaissance Woodbridge Hotel. This distinctive hotel in Edison, New Jersey, features 269 modern guest rooms, including 42 suites, and more than 25,000 square feet of flexible meeting space. Our hotel's location is centrally located amidst corporate offices and tourist attraction. Our accommodations stand out from other hotels in Edison, NJ, and provide a sophisticated retreat for families and business travelers alike. Marriott's Plug-in panels and 37-inch LCD HD TVs allow guests simultaneous connectivity to laptops, iPods and DVD players. We are one of the most conveniently situated hotels at the crossroads of U.S. Routes 1 and 9. We are also just five minutes from Woodbridge Center Mall, 15 minutes south of Newark Liberty International Airport (EWR) and less than one mile from the Metropark train station. With our premier location and amenities, our Edison accommodations provide an advantageous travel destination.

2018 Speakers

2018 Agenda

Media Partners

The Medicine Maker

Samedan

International Clinical Trials (ICT) is a quarterly magazine edited by Dr Graham Hughes, and written by specialists at the forefront of clinical research. ICT’s coverage of operational developments ranges from adaptive designs in early phase trials through to post marketing research. ICT’s targeted readership consists of key decision makers across the pharmaceutical and biotech industries, along with contract partners and consultants. The magazine is distributed to pharmaceutical professionals in Europe and North America, and is accessed globally online. Read the latest issues, explore the ICT archive and subscribe at www.samedanltd.com/magazine/13.

Farmavita

Farmavita Net is professional community and network of pharmaceutical licensing and business development executives, innovators and researchers Farmavita.Net is the pharmaceutical licensing, technology transfer and regulatory affairs network. We are managing the marketplace of offers and demand for pharmaceutical Dossiers, know-how and technologies. Members of Farmavita.Net network usually find a number of attractive solutions for business development, alliances, joint ventures, co-development and co-marketing of pharmaceutical products. Farmavita.Net is not just a pure Internet portal. We manage a number of regional associates. We are connecting the dynamic network of few hundreds members / pharmaceutical companies interested in license-in and license-out opportunities.

GaBI

Generics and Biosimilars Initiative (GaBI) was founded in 2008. GaBI aims to foster the worldwide efficient use of high quality and safe medicines at an affordable price, thus advancing and supporting the idea of accessible, affordable and sustainable health care.
The objective of GaBI is to raise the scientific status of generic and biosimilar medicines, via well-documented and up-to-date information about generic and biosimilar medicines both in print (www.gabi-journal.net) and electronically (www.gabionline.net) in an open access format, providing high quality, scientifically sound and reliable information to healthcare professionals including physicians, pharmacists and nurses, consumers, drug developers, third-party payers, legislators and assessors; who are in need of a reliable, critical and independent source of information on all aspects of generic and biosimilar medicines.
Subscribe to gain easy access of information on the latest scientific research and developments in generic and biosimilar medicines via GaBI Online to editorial@gabionline.net; or submit a manuscript to GaBI Journal to editorial@gabi-journal.net.
GaBI’s mission – Building trust in cost-effective treatments

Biosimilar Development

Biosimilar Development is dedicated to presenting technical information, thought leadership, and commentary for the biosimilar development and manufacturing community. On this site, users will find exclusive and actionable content on the industry trends and challenges affecting the emerging biosimilars market. Browse our articles, case studies, and white papers on topics related to biosimilar development, manufacturing, quality, distribution, FDA guidance, BPCIA, global markets, government regulations, and intellectual property.
Biosimilar Development is part of the Life Science Connect media group, which strives to facilitate connections and foster collaborations in pharmaceutical development to find ways to get more life-saving and life-improving therapies to market. Connect, Collaborate, Contribute.

Pharma Journalist

Pharma Journalist is a product of Kellen Media. Pharma Journalist is one of the leading website covering the need of global Pharmaceutical Industry.
Articles like latest news, trends, analysis, market report, press releases, whitepapers, case studies, etc. published on pharmajournalist.com helps Industry professionals and decision makers to stay on the top of this fast-paced industry.
Pharma Journalist aims of providing fast and informative articles to its readers and subscribers.

The Center of Biosimilars

About Us
Health economics experts. Managed care professionals. Key clinical specialists.
This is where the worlds of clinical, regulatory, and economical outcomes for specialized pharmaceutical biotechnology meet: The Center for Biosimilars is your online resource for emerging technologies, with a focus on improving critical thinking in the field to impact patient outcomes.
We’ll discuss the current landscape for advanced health care management—reviewing emerging treatment paradigms, approaches, and considerations—all by authoritative industry voices.

World Pharma News

Media Partners

Open Chemistry

Open Chemistry (IF - 1.425) is a peer-reviewed, open access journal that publishes original research, reviews and short communications in the fields of chemistry in an ongoing way. Our central goal is to provide a hub for researchers working across all subjects to present their discoveries, and to be a forum for the discussion of the important issues in the field.

SciDoc Publishers

SciDoc Publishers is a major source provider of e-journals in the field of Science, Technology and Medicine (STM). The nature of journals - Open Access and Peer-reviewed. We are aimed with a sole motive in making a mark in the field of Open Access, by propagating the knowledge to the scientific community. Our prime concern involves, the knowledge to reach millions of readers and give them access to scientific publications - online.

Labcompare

Labcompare is a product of American Laboratory, and is already included in the AL logo on your website. I have attached the standalone Labcompare logo and info is below, but if you do add this one separately, could you exchange the American Lab logo with the one attached?
For laboratory managers and researcher scientists across analytical chemistry and applied sciences who need to find product solutions, advice, and access scientific tools. Labcompare provides an industry-leading, comprehensive, online resource of product information to support the laboratory’s needs. Labcompare supports every step of the buying journey by focusing on core and new product technology, supplies, tips, and buyer’s guides.

Pharmaceutical Outsourcing

Pharmaceutical Outsourcing, the journal dedicated to pharmaceutical and biopharmaceutical contract services. With regular sections on contract manufacturing, contract research, contract packaging, formulation/development services, contract analytical testing, APIs, stability testing, clinical research and other areas, we bring the most complete coverage of trends and issues in the industry to our 15,000 readers in North America.

Biocompare

Biocompare.com is the leading resource for up-to-date product information, product reviews, and new technologies for life scientists. Biocompare combines an in-depth knowledge of life science products and new technologies with the power of the Internet to offer scientists the most dynamic, relevant, and innovative media-based marketplace for life science information.

Technology Networks

Founded in 2000, Technology Networks is established as the leading news provider for life science and drug discovery professionals. In addition, we provide unique content including webcasts, videos, application notes and posters from recent conferences. Our portfolio now includes around 30 focussed scientific communities, all of which are accessible free of charge within TechnologyNetworks.com

American Pharmaceutical Review

Start receiving your free copy today. American Pharmaceutical Review is a review of the drug pipeline from the late discovery phase through manufacturing. American Pharmaceutical Review prides itself on having the most relevant, unbiased and informative editorial in the industry. You will find that all of our editorial is highly technical and written by government agencies, consultants, academics, and large pharmaceuticals companies. American Pharmaceutical Review covers several key topics that are important to drug production:Separations and purification, Drug Delivery, Biopharmaceutical Processing, Biopharmaceutical Development, Formulation development, Manufacturing, Microbiology, Instrumentation, Spectroscopy

The ASD Media platforms are well known and used intensively, your company is able to benefit from these large numbers of users. Be informed with ASD-Network; Create exposure for your company with ASDSource, distribute your news with ASDWire or advertise with us, build your brand and increase traffic to your company’s website.

Pharmalicensing

Pharmalicensing (www.pharmalicensing.com) is the premier biopharmaceutical Open Innovation resource designed for professionals involved with partnering, licensing and business development worldwide.
Actively supporting all forms of partnering and in- and out-licensing activities, Pharmalicensing utilizes the unique online Showcase Profiling & Discover services, as well as its renowned Partnering Search service leveraging its global network of industry experts, to enable companies to identify and engage with appropriate partners around the world.
Pharmalicensing is actively utilized by many tens of thousands of industry professionals each month. Pharmalicensing is a division of Cognis Group, Inc.

American Laboratory

For laboratory managers and researchers utilizing analytical chemistry and its applications, seeking knowledge on new technologies, methods, applications, and products, the American Laboratory® publication platform provides comprehensive technology coverage for laboratory professionals at all stages of their careers. Unlike single-channel publications, American Laboratory® is a multidisciplinary resource that engages scientists through print, digital, mobile, multimedia, and social channels to provide practical information and solutions for cutting-edge results. American Laboratory® serves the need of global community of laboratory professionals for communicating relevant technical advances and insights. Globally, American Laboratory® reaches out to subscribers by offering digital distribution plus premium print in North America. Digital communications utilize internet, mobile and social channels.

Bentham Science

Bentham Science Publishers is a major STM journal publisher of 130 plus print and online journal. Out of these, 40 journals have already registered good IMPACT FACTORS as per Journal Citation Reports® 2017. These titles have extensive readership mostly in Europe and North America. For a detailed profile please visit our website at http://www.benthamscience.com. Besides, Bentham Science publishes eBooks in all areas of Science, Technology and Medicine. Our eBooks provide professionals, academicians, corporate researchers, graduates and undergraduates worldwide with the most current information in their subject areas of interest. Our eBooks are also available in the ePub and Kindle formats besides the PDF edition here http://ebooks.benthamscience.com/.
Bentham is offering attendees of this conference discounts on its publication. For more information click here

Gate2Biotech

Gate2Biotech is a portal that unites biotechnological community in Central Europe. It covers all the news in the field of biotechnology. Thanks to the the portal the companies engaged in the field can easily search for research institutions and other partners to solve technical problems they are facing and here they can also present their services offer to potential partners from the Czech Republic and abroad. Gate2Biotech portal serves as a bridge connecting scientific and commercial sector. It incorporates offices and support organizations dedicated to promoting transfer of innovative technologies into a unified communication platform of Czech and international biotechnologies. As a mediator of information it draws attention to biotechnologies and support of their application and transfer into practice. It also functions as a tool for encouraging non-professionals (especially scientists and students) towards innovative business or applied research.

pharmaphorum

pharmaphorum drives innovation within the pharmaceutical industry, by bringing healthcare together through a suite of media services that help produce and disseminate thought leadership, combined with an online platform for communicating messages to a global audience.Visit www.pharmaphorum.com

Mednous

MedNous is a print publication and website about medical innovation in Europe. It carries exclusive interviews with companies that are at the forefront of medical technology, as well as contributor articles from prominent practitioners. Our mission is to identify significant advances in medicine and to explain how this innovation is being commercialised. In doing so, we talk to venture capitalists about what products and platforms they are supporting. We report on how regulators cope with the accelerating pace of innovation. And we regularly cover the latest developments in the discovery and development of new medical concepts in the area of antibodies, vaccines, small molecules, regenerative medicine and nanomedicines. MedNous combines the English word for medicine with the Greek word for intellect. And those with nous are readers of our publication. Visit our website: www.mednous.com

SAVE TO

Renaissance Woodbridge Hotel

515 US Highway 1 South
Iselin 08830
USA

Your simple delights will become memorable moments at Renaissance Woodbridge Hotel. This distinctive hotel in Edison, New Jersey, features 269 modern guest rooms, including 42 suites, and more than 25,000 square feet of flexible meeting space. Our hotel's location is centrally located amidst corporate offices and tourist attraction. Our accommodations stand out from other hotels in Edison, NJ, and provide a sophisticated retreat for families and business travelers alike. Marriott's Plug-in panels and 37-inch LCD HD TVs allow guests simultaneous connectivity to laptops, iPods and DVD players. We are one of the most conveniently situated hotels at the crossroads of U.S. Routes 1 and 9. We are also just five minutes from Woodbridge Center Mall, 15 minutes south of Newark Liberty International Airport (EWR) and less than one mile from the Metropark train station. With our premier location and amenities, our Edison accommodations provide an advantageous travel destination.

Cookie Policy

From May 2011 a new privacy law came into effect across the EU. The law requires
that websites ask visitors for consent to use most web cookies. We use cookies to
ensure you get the best experience on our website –Tick here to accept cookie use
Details of our cookie use may be found here.

WHAT IS CPD?

CPD stands for Continuing Professional Development’. It is essentially a philosophy,
which maintains that in order to be effective, learning should be organised and
structured. The most common definition is:

‘A commitment to structured skills and knowledge enhancement for Personal or Professional
competence’

CPD is a common requirement of individual membership with professional bodies and
Institutes. Increasingly, employers also expect their staff to undertake regular
CPD activities.

Undertaken over a period of time, CPD ensures that educational qualifications do
not become obsolete, and allows for best practice and professional standards to
be upheld.

CPD can be undertaken through a variety of learning activities including instructor
led training courses, seminars and conferences, e:learning modules or structured
reading.

CPD AND PROFESSIONAL INSTITUTES

There are approximately 470 institutes in the UK across all industry sectors, with
a collective membership of circa 4 million professionals, and they all expect their
members to undertake CPD.

For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked
to a licence to practice, for others it’s obligatory. By ensuring that their members
undertake CPD, the professional bodies seek to ensure that professional standards,
legislative awareness and ethical practices are maintained.

CPD Schemes often run over the period of a year and the institutes generally provide
online tools for their members to record and reflect on their CPD activities.

TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

Professional bodies and Institutes CPD schemes are either structured as ‘Input’
or ‘Output’ based.

‘Input’ based schemes list a precise number of CPD hours that individuals must achieve
within a given time period. These schemes can also use different ‘currencies’ such
as points, merits, units or credits, where an individual must accumulate the number
required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of
learning.

‘Output’ based schemes are learner centred. They require individuals to set learning
goals that align to professional competencies, or personal development objectives.
These schemes also list different ways to achieve the learning goals e.g. training
courses, seminars or e:learning, which enables an individual to complete their CPD
through their preferred mode of learning.

As a formal provider of CPD certified activities, SMI Group can provide an indication
of the learning benefit gained and the typical completion. However, it is ultimately
the responsibility of the delegate to evaluate their learning, and record it correctly
in line with their professional body’s or employers requirements.

GLOBAL CPD

Increasingly, international and emerging markets are ‘professionalising’ their workforces
and looking to the UK to benchmark educational standards. The undertaking of CPD
is now increasingly expected of any individual employed within today’s global marketplace.

CPD Certificates

We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@smi-online.co.uk